ATX-101 Abdominoplasty (ATX-101-08-10)

This study has been completed.
Sponsor:
Information provided by:
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00835952
First received: February 3, 2009
Last updated: January 25, 2010
Last verified: January 2010
  Purpose

Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty


Condition Intervention Phase
Characteristics of Subcutaneous Fat
Drug: ATX-101
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Phase 1, Open-label Study of the Safety, Tolerability, and Histological Effect of Single Doses of ATX-101 (Sodium Deoxycholate for Injection) Administered in Abdominal Fat in Subjects Undergoing Abdominoplasty

Further study details as provided by Kythera Biopharmaceuticals:

Primary Outcome Measures:
  • Adverse events, laboratory test results, physical examinations [ Time Frame: 1 - 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histopathology [ Time Frame: 1 - 28 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: November 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATX-101 Drug: ATX-101
ATX-101 single doses

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects undergoing planned abdominoplasty

Exclusion Criteria:

  • History of interventions in the abdominal area
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835952

Locations
United States, California
San Francisco, California, United States
Santa Monica, California, United States
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
Study Director: Patricia Walker, M.D., Ph.D. Kythera Biopharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Director, Clinical Affairs, Kythera Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00835952     History of Changes
Other Study ID Numbers: ATX-101-08-10
Study First Received: February 3, 2009
Last Updated: January 25, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 18, 2014